Studies
| Study First Submitted Date | 2020-12-09 |
| Study First Posted Date | 2020-12-16 |
| Last Update Posted Date | 2021-10-14 |
| Start Month Year | August 20, 2021 |
| Primary Completion Month Year | October 12, 2021 |
| Verification Month Year | December 2020 |
| Verification Date | 2020-12-31 |
| Last Update Posted Date | 2021-10-14 |
Detailed Descriptions
| Sequence: | 20746958 |
| Description | The use of telemedicine in musculoskeletal assessment has been historically low. The current COVID 19 global pandemic has forced a paradigm shift with many centers rapidly adopting virtual visits to conduct care resulting in rapid expansion of the use of telemedicine amongst practices. Mayoclinic has published The Telemedicine Musculoskeletal Examination for adults. 'Paediatric Musculoskeletal Matters' (PMM- www.pmmonline.org, is a free, evidence-based, and peer-reviewed open e-resource for pediatric musculoskeletal (MSK) medicine targeting non-MSK specialists. They have also published video Pediatric Gait, Arms, Legs and Spine (V-pGALS), an assessment sheet for telemedicine visits on their webpage. However, there is a lack of the acceptability and reliability of these tools. The aim of this study is to investigate acceptability and reliability of real-time virtual video Pediatric Gait, Arms, Legs and Spine (V-pGALS) assessment for musculoskeletal assessment of children for telemedicine visits. For this purpose, children at between the ages of 7-18 who admitted the Pediatric Rehabilitation outpatient clinic of Department of Physical Medicine and Rehabilitation of Marmara University School of Medicine will be recruited to the study. They will be evaluated via V-pGALS face to face on the day of admission and the physiatrist will record the diagnosis if there is. Within 24 hours the child will be reevaluated via V-pGALS by using Zoom application virtually. The acceptability of V-pGALS examination to the child and parents in terms of the duration and additional discomfort caused was evaluated using visual analog scale with smiley faces (0-10, 0 for full acceptability). |
Facilities
| Sequence: | 200317808 |
| Name | Marmara University School of Medicine Department of Physical Medicine and Rehabilitation |
| City | Istanbul |
| Zip | 34899 |
| Country | Turkey |
Conditions
| Sequence: | 52235615 | Sequence: | 52235616 |
| Name | Musculoskeletal Abnormality | Name | Pediatric |
| Downcase Name | musculoskeletal abnormality | Downcase Name | pediatric |
Id Information
| Sequence: | 40205742 |
| Id Source | org_study_id |
| Id Value | 09.2020.1 |
Countries
| Sequence: | 42619838 |
| Name | Turkey |
| Removed | False |
Design Groups
| Sequence: | 55665812 |
| Group Type | Experimental |
| Title | Children who admit to Pediatric Rehabilitation outpatient clinic |
| Description | Children who admit to Pediatric Rehabilitation outpatient clinic of the Department of Physical Medicine and Rehabilitation will be evaluated by face to face and virtually by using zoom application via video Pediatric Gait, Arms, Legs and Spine (V-pGALS) |
Interventions
| Sequence: | 52549317 |
| Intervention Type | Diagnostic Test |
| Name | video Pediatric Gait, Arms, Legs and Spine (V-pGALS) |
| Description | The Video-pGALS includes maneuvers from pediatric regional examination of the musculoskeletal system (pREMS) and derived from the pediatric gait arms legs spine examination assessment which is a validated simple basic musculoskeletal (MSK) examination for children. V-pGALS offers a structured approach to a cursory overview MSK exam with a focus on range of movement and symmetry. Utilizing the parent or caregiver to feel the joint in question for obvious warmth/ swelling or to palpate for point of maximal tenderness can add important information. |
Keywords
| Sequence: | 79960635 | Sequence: | 79960636 | Sequence: | 79960637 | Sequence: | 79960638 | Sequence: | 79960639 | Sequence: | 79960640 | Sequence: | 79960641 |
| Name | telemedicine | Name | pandemic | Name | video Pediatric Gait, Arms, Legs and Spine (V-pGALS) | Name | pediatric examination | Name | musculoskeletal examination | Name | reliability | Name | acceptability |
| Downcase Name | telemedicine | Downcase Name | pandemic | Downcase Name | video pediatric gait, arms, legs and spine (v-pgals) | Downcase Name | pediatric examination | Downcase Name | musculoskeletal examination | Downcase Name | reliability | Downcase Name | acceptability |
Design Outcomes
| Sequence: | 177613039 | Sequence: | 177613040 | Sequence: | 177613041 | Sequence: | 177613042 | Sequence: | 177613043 | Sequence: | 177613044 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Face to face examination of video Pediatric Gait, Arms, Legs and Spine (V-pGALS) | Measure | real-time virtual video Pediatric Gait, Arms, Legs and Spine (V-pGALS) | Measure | Acceptability of V-pGALS examination to the child in terms of the duration | Measure | Acceptability of V-pGALS examination to the child in terms of the additional discomfort caused | Measure | Acceptability of V-pGALS examination to the parent who will be present during examination in terms of the duration | Measure | Acceptability of V-pGALS examination to the parent who will be present during examination in terms of the additional discomfort caused |
| Time Frame | Day 0 | Time Frame | Day 1 | Time Frame | Day 1 | Time Frame | Day 1 | Time Frame | Day 1 | Time Frame | Day 1 |
| Description | Face to face examination | Description | Video real-time examination via zoom application | Description | visual analog scale with smiley faces (0-10, 0 for full acceptability) | Description | visual analog scale with smiley faces (0-10, 0 for full acceptability). visual analog scale with smiley faces (0-10, 0 for full acceptability). visual analog scale with smiley faces (0-10, 0 for full acceptability). visual analog scale with smiley faces (0-10, 0 for full acceptability). visual analog scale with smiley faces (0-10, 0 for full acceptability) | Description | visual analog scale with smiley faces (0-10, 0 for full acceptability) | Description | visual analog scale with smiley faces (0-10, 0 for full acceptability) |
Browse Conditions
| Sequence: | 193732243 | Sequence: | 193732244 | Sequence: | 193732245 |
| Mesh Term | Musculoskeletal Abnormalities | Mesh Term | Congenital Abnormalities | Mesh Term | Musculoskeletal Diseases |
| Downcase Mesh Term | musculoskeletal abnormalities | Downcase Mesh Term | congenital abnormalities | Downcase Mesh Term | musculoskeletal diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48379871 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Marmara University |
Overall Officials
| Sequence: | 29320648 | Sequence: | 29320649 | Sequence: | 29320650 | Sequence: | 29320651 |
| Role | Study Chair | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator |
| Name | Evrim Karadag-Saygı, Prof | Name | Esra Giray, assoc. prof | Name | Özden Ozyemisci Taskiran, Prof | Name | Ozge Kenis-Coskun, assoc. prof |
| Affiliation | Marmara University School of Medicine Department of Physical Medicine and Rehabilitation | Affiliation | Koc University School of Medicine Department of Physical Medicine and Rehabilitation | Affiliation | Koc University School of Medicine Department of Physical Medicine and Rehabilitation | Affiliation | Marmara University School of Medicine Department of Physical Medicine and Rehabilitation |
Design Group Interventions
| Sequence: | 68236500 |
| Design Group Id | 55665812 |
| Intervention Id | 52549317 |
Eligibilities
| Sequence: | 30803088 |
| Gender | All |
| Minimum Age | 7 Years |
| Maximum Age | 18 Years |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Criteria | Inclusion Criteria: Children between the ages of 7-18 who admitted the Pediatric Rehabilitation outpatient clinic of Department of Physical Medicine and Rehabilitation Exclusion Criteria: Non-ambulatory children Children with poor cooperation Being severe ill and unable to tolerate examination Children and parents who do not give oral and written permission for study enrollment |
| Adult | True |
| Child | True |
| Older Adult | False |
Calculated Values
| Sequence: | 254020122 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2020 |
| Actual Duration | 1 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 7 |
| Maximum Age Num | 18 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 2 |
| Number Of Secondary Outcomes To Measure | 4 |
Designs
| Sequence: | 30549102 |
| Allocation | N/A |
| Intervention Model | Single Group Assignment |
| Observational Model | |
| Primary Purpose | Diagnostic |
| Time Perspective | |
| Masking | None (Open Label) |
| Masking Description | Two phsyiatrist who will perform virtual video Pediatric Gait, Arms, Legs and Spine (V-pGALS) and the physiatrist who will perform face to face examination will be blinded to each other |
| Intervention Model Description | Children between the ages of 7-18 who admit pediatric rehabilitation outpatient clinic |
Responsible Parties
| Sequence: | 28915446 |
| Responsible Party Type | Sponsor |
Study References
| Sequence: | 52134316 | Sequence: | 52134317 | Sequence: | 52134318 | Sequence: | 52134319 |
| Pmid | 28926470 | Pmid | 2753146 | Pmid | 33129319 | Pmid | 35319535 |
| Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | derived |
| Citation | Batu ED, Kenis Coskun O, Sonmez HE, Karali D, Arslanoglu Aydin E, Bilginer Y, Karadag Saygi E, Ozen S. Acceptability and Practicality of the Turkish Translation of Pediatric Gait Arm Legs and Spine in Turkish Children. J Clin Rheumatol. 2017 Dec;23(8):421-424. doi: 10.1097/RHU.0000000000000586. | Citation | Pelaez F, de Haro C. Translational inhibition by eIF-2-phospholipid complex in mammalian cell-free systems. FEBS Lett. 1989 Jul 3;250(2):523-8. doi: 10.1016/0014-5793(89)80789-6. | Citation | Shenoi S, Hayward K, Curran ML, Kessler E, Mehta JJ, Riebschleger MP, Foster HE. Telemedicine in pediatric rheumatology: this is the time for the community to embrace a new way of clinical practice. Pediatr Rheumatol Online J. 2020 Oct 31;18(1):85. doi: 10.1186/s12969-020-00476-z. | Citation | Giray E, Kenis-Coskun O, Karadag-Saygi E, Ozyemisci-Taskiran O. Interrater Reliability, Acceptability, and Practicality of Real-Time Video Pediatric Gait, Arms, Legs, and Spine for Musculoskeletal Assessment of Children During Telemedicine Visits. J Clin Rheumatol. 2022 Aug 1;28(5):235-239. doi: 10.1097/RHU.0000000000001840. Epub 2022 Mar 22. |